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CHEST P H YSICIAN • NOVEMBER 2007
The Perils of Pseudo-Compounded Medications
Physicians have a major responsibility to ensure
submits an order for a nebulizer, the sup-
Ǡ Receiving, storing, or using drug sub-
plier will offer a free nebulizer if the pa-
stances without first obtaining written as-
the safety of their patients’ medications.
tient gets his medication from the supplier,
surance from the supplier that each lot of
ecently, there has been a significant with ink that can leach into the solutions, un- plier bills the insurance company or FDA-registered facility.
Medicare, and the medication is virtually
Ǡ Failing to conform to applicable state law
labeling is embossed in the plastic, to avoid
cost-free. This sounds like a good deal, ex-
this problem. There are well-documented in-
cept for the fact that the medications are
stances of each of these problems where unreliable and can even be dangerous.
Special Risks of Pharmacy Compounding.
not well regulated. Many less heavily pub-
drugs may also be obtained deceptively.
for patient advocacy groups and specialty
Update, May 3, 2007: The Special Risks of
frequently, the form does not make it clear
that a substitution is being requested. In ad-
cialize in respiratory diseases need to be
especially vigilant, because many of these
that pharmacies are not required to report
other commonly “compounded” drugs.
events include: (1) three patients who died
SPECIALIZE IN RESPIRATORY
of infections acquired by cardioplegic so-
lutions during open-heart surgery; (2) two
DISEASES NEED TO BE
response to a physician’s prescription, to
fected solutions during cataract surgery;
meet the needs of a specific patient. This
(3) three patients who died of Serratia-in-
BECAUSE MANY OF THESE
is an invaluable service rendered for pa-
fested injectable beclomethasone; and (4)
MEDICATIONS ARE USED IN
18 cases of Serratia marcescens
tions that are not commercially available,
people who may be allergic to inactive in-
sulfate IV solution (Sunenshine et al. Clin
2007; 45:527). A particularly egre-
unaware that they are signing off on drugs
that are not FDA-approved and of inferior
4,000 L of respiratory solutions to be used
quality. One could speculate that the “com-
macies” exist that are engaged in the mass
for nebulization and distributed them pounding” manufacturers and distributors
manufacturing of drugs under the guise of
nationwide to 18,000 patients. These med-
are counting on physicians being too busy
ications were contaminated with Pseudo-
to scrutinize what they are signing.
produce millions of doses of their product
Is there any peril to physicians if a pa-
in anticipation of a physician’s order. The
notified doctors or patients about the con-
tient becomes ill as a result of taking such
equipment companies is FDA-approved.
tamination and destroyed critical records.
a medicine? In fact, it is the physician who
It was ultimately disciplined by the state
becomes liable for the adverse events.
Board of Pharmacy, which, in Missouri, is
Physicians have a major responsibility to
process. Pharmacists running these opera-
tion, the pharmacist preparing the drug is
ensure the safety of their patients’ med-
ications. They must read all their faxes for
is supposed to be regulated at a state level
prescriptions before they sign them. They
by state pharmacy boards. Yet the FDA can
protect patients and physicians from these
also need to read the fine print to ensure
intervene, and has intervened, when it can
medications are the same as in their com-
manufacturers claim that they have gener-
ic versions of drugs, which are, in fact, not
trigger its intervention. To the extent the
that the medications they prescribe are dis-
FDA can intervene with limited resources,
pensed as written and their patients’ med-
bling. States do not have the resources nec-
available in this country. An example is the
it has intervened. This list also is instruc-
essary to inspect compounding pharmacies,
tive in identifying the behaviors of these
be aware that, if their patients are not
and some states have only a handful of in-
pharmacies that put them in conflict with
spectors to cover the entire state, which al-
proper manufacturing practices. These be-
lows for some extremely shoddy practices by
the “compounders.” The raw materials used
that is aqueous-soluble. Budesonide is no-
for their preparations are not FDA-approved,
so it is impossible to determine their prove-
“compounders” dissolve it in high con-
were found to be unsafe or ineffective.
medication their patients inhale, ingest,
or apply, it conforms to the highest pos-
processes are often not sterile, and prepara-
ly copies of a commercially available drug.
tions have been unevenly potent, causing the
patients, including children, via nebuliza-
“compounded” products are not surrep-
tion. Ethanol is very irritating to the lungs
ceiving prescriptions, except in very limit-
tients. In addition, plastic ampules of drugs
and, in these cases, is being given to pa-
for nebulizer formulations have paper labels
Dr. Gene L. Colice, FCCP
are deceptive to physicians and patients. In
and Clinical Professor of Medicine
hiv & aids treatment in practiceIsoniazid preventive therapy for TB in people withHIV: barriers to national implementation - 29/11/2007The current outcome data for the Botswana IPT programmeGetting the HIV programme, and health providers to ‘buy in’ to IPTExcluding active disease: is chest x-ray necessary?What about excluding smear negative (SNTB) and extrapulmonary disease (EPTB)?
The Beer lists are used as a national guideline and reference guide forpharmacists and physicians to improve the use of medication in the elderly. Forseveral years, gerontologist Mark H. Beers, MD, has been advocating the use ofexplicit criteria-developed through consensus panels-for identifying inappropriateuse of medications. In a 1991 paper that looked at the nursing facility population,he wrot